UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054604 |
|---|---|
| Receipt number | R000062389 |
| Scientific Title | An Empirical Study of the Effects of Memory-Enhancing Eyewear on Sleep and Learning |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2024/10/14 13:13:11 |
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Basic information
Public title
An Empirical Study of the Effects of Memory-Enhancing Eyewear on Sleep and Learning
Acronym
Effects on Learning and Sleep Testing in Eyewear
Scientific Title
An Empirical Study of the Effects of Memory-Enhancing Eyewear on Sleep and Learning
Scientific Title:Acronym
Effects on Learning and Sleep Testing in Eyewear
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify the effects of wearing long-wavelength blue light cut glasses on learning and sleep for male and female elementary and junior high school students between the ages of 9 (4th grade) and 15 (3rd grade), an evaluation of concentration and cognitive functions, an evaluation of mental health, an evaluation of the amount of activity at home, an objective evaluation of sleep by measuring brain waves and other biopotentials from bedtime to awakening The objective evaluation of sleep by measuring brain waves and other bioelectrical potentials from bedtime to awakening, and subjective evaluation of sleep using a sleep questionnaire upon awakening will be conducted.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To examine the effects of wearing eyewear on sleep by calculating each sleep parameter (total sleep time, sleep efficiency, sleep latency, mid-wake time, total time and percentage of deep sleep time, etc.) when wearing the three types of eyewear, respectively. In addition, parameters related to subjective sleep quality as scored by subjective sleep assessment (OSA-MA) will be calculated and examined respectively.
2. to examine the effects of wearing eyewear on daily changes in concentration and cognitive function.
Key secondary outcomes
1. To examine changes over time in activity meters and the effects of wearing eyewear. 2.
2. To examine changes in mental health and the effects of wearing eyewear.
3. To examine the subjective evaluation of eyewear use and light intensity.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Three types of eyewear are to be worn in order of their assigned type.
Interventions/Control_2
Three types of eyewear are to be worn in order of their assigned type.
Interventions/Control_3
Three types of eyewear are to be worn in order of their assigned type.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese who are at least 9 years old and less than 12 years old at the time of consent
2. Individuals who have obtained written consent to participate in the study from the participant and a surrogate.
Key exclusion criteria
1. Those who regularly consume food for specified health use, functional foods, supplements, or health foods that may affect the study at least 3 times a week, and those who are unable to limit their intake during the study period.
2. Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc.
3. Persons suspected of having a chronic or acute serious infectious disease.
4. Those who are scheduled to be vaccinated during the study period.
5. Those who have an extremely irregular diet.
6. Those who plan to change their lifestyle drastically during the study period.
7. Who are currently participating in a clinical study of another drug or health food, and who plan to participate in another clinical study within one month after the completion of the study, or after consent to participate in the study.
8.Any other person who is deemed by the principal investigator to be inappropriate to participate in this study.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Kawato |
Organization
Mitsui Chemicals, Inc.
Division name
Marketing & Innovation Department, New Business Incubation Center
Zip code
104-0028
Address
2-2-1 Yaesu, Chuo-ku, Tokyo
TEL
070-4073-1202
nobuo.kawato@mitsuichemicals.com
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Kondo |
Organization
Benesse Corporation
Division name
Elementary School Business Division
Zip code
206-8686
Address
1-34 Ochiai, Tama City, Tokyo
TEL
070-8801-1968
Homepage URL
kondo.reiko@mail.benesse.co.jp
Sponsor or person
Institute
Mitsui Chemicals, Inc.
Institute
Department
Personal name
Funding Source
Organization
Mitsui Chemicals, Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Association Sapporo Yurinokai Hospital
Address
11-186 Yurigahara, Kita-ku, Sapporo, Japan
Tel
011-771-1501
info@yurinokai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062389
